[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581109":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":59,"collaborators":19,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":19,"overallStatus":42,"whyStopped":19,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Poitiers University Hospital","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"acute hypoxia","The participant will be exposed to 2 sequences : a 3-hour normoxia period and then a 2-hour hypoxia (FiO2=14.26% corresponding to 3000m altitude) period.",[12,13],"Other: Hypoxia administration study group","Combination Product: Renal clairance study",[15,20],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Hypoxia administration study group","Acute 2-hour hypoxia (14.5%FiO2 corresponding to 3000m altitude)",[9],null,{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":19},"COMBINATION_PRODUCT","Renal clairance study","Assessment of renal clearance by measuring Glomerular Filtration Rate (GFR) after two agents infusion:\n\n* Aminohippurate Sodium (or or para-aminohippuric acid \\[PAH\\]) Inj 20% Diagnostic agent used to measure effective renal plasma flow (ERPF)\n* Iohexol Inj 300 MG\u002FML Diagnostic agent used to measure glomerular filtration rate (GFR)",[9],[26],{"name":27,"affiliation":28,"role":29},"Pierre Jean SAULNIER, MD PhD","CHU Poitiers","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":19,"email":35},"Emilie RABOIS, MSc","CONTACT","+330549444686","emilie.rabois@chu-poitiers.fr",{"name":37,"role":33,"phone":19,"phoneExt":19,"email":38},"Céline DELETAGE METREAU, PhD","Celine.DELETAGE-METREAU@chu-poitiers.fr",[40],{"facility":41,"status":42,"city":43,"state":19,"zip":19,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Centre Investigation Clinique CIC1402 - CHU Poitiers","RECRUITING","Poitiers","France","FR",{"type":47,"coordinates":48},"Point",[49,50],0.34348,46.58261,{"lat":50,"lon":49},[53,55,56],{"name":32,"role":33,"phone":54,"phoneExt":19,"email":35},"+33(0)549444689",{"name":27,"role":29,"phone":19,"phoneExt":19,"email":19},{"name":57,"role":58,"phone":19,"phoneExt":19,"email":19},"Christophe RAULT, MD PhD","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100581109","effect-of-acute-hypoxia-on-renal-hemodynamic-in-healthy-volunteers-patients-with-diabetes-and-patients-with-diabetes-and-kidney-disease-100581109",false,"NCT06846034","Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease","Effect of Acute Hypoxia on Renal Hemodynamic in Healthy Volunteers, Patients With Diabetes and Patients With Diabetes and Kidney Disease : Pilot Study.","DIAKIPOX","Inclusion Criteria:\n\nFor all participant :\n\n1. No history of respiratory diseases\n2. Affiliated person or beneficiary of the French social security scheme.\n3. signed informed consent\n\nGroup 1 ( For healthy volunteers):\n\n1. \\[18; 40\\] years old\n2. No history of diabetes\n3. No acute\u002Flong term \\> 3 months drug use except contraception\n4. BMI: \\[18,5 - 29,9\\]kg\u002Fm2\n5. eGFR \\> 60ml\u002Fmin\u002F1.73m2\n6. Normal to midly increased albuminuria: defined as ACR \\\u003C 3 mg\u002Fmmol\n\nFor all the patients with T2D (group 2 and 3):\n\n1. Diagnosed T2D according to ADA criteria\n2. \\[35; 75\\] years old\n3. Stable treatment of diabetes and\u002For antihypertension for at least 2 months prior to inclusion\n4. No proliferative diabetic retinopathy\n\nGroup 2 - For patients with T2D and no DKD:\n\n* eGFR \\> 60ml\u002Fmin\u002F1.73m2 and\n* Normal to midly increased albuminuria: defined as ACR \\\u003C 3 mg\u002Fmmol\n\nGroup 3 - For patients with DKD:\n\n* eGFR \\[45-60 ml\u002Fmin\u002F1.73m2\\] and\u002For\n* Moderately to severely increased ACR ≥ 3 mg\u002Fmmol\n\nExclusion Criteria:\n\nFor all participants:\n\n1. Active smoking\n2. Contraindication to any of the agent (PAH, or iohexol or gadolinium) used in the study.\n3. Contraindication to cardiac MRI, renal MRI, respiratory tests,\n4. History acute coronary syndrome or coronary revascularization\n5. Recent (\\\u003C6 months) history of: Heart failure requiring hospitalisation or Stroke or transient ischemic neurologic disorder\n6. Severe unstable hypertension (≥180 mmHg systolic or ≥110 mmHg diastolic blood pressure)\n7. Resting oxygen saturation \\\u003C95% at baseline\n8. Any concomitant disease or condition that may interfere with the safety or the possibility for the patient to comply with or complete the study protocol.\n9. History of severe mountain sickness (dizziness, headache, nausea\u002Fvomiting and incapaciting fatigue)\n10. Consumption of SGLT2 inhibitors\n11. Concurrent participation in another clinical research study\n12. Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception\n13. Persons benefiting from enhanced protection under french national law\n14. Persons under psychiatric care who are unable to give their consent",true,"ALL","18 Years","75 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"NA","Diabetes mellitus is a non-transmissible disease whose incidence is growing worldwide .\n\nThis pathology is defined by a chronic hyperglycaemia linked to a deficiency of either insulin secretion or its action or both. This increased prevalence is linked to the growing of the obese population on one hand, and to the ageing of the population, on the other hand, which is associated with an increased prevalence of metabolic diseases. The number of patients with diabetes, particularly type 2 diabetes (T2D) is regularly increasing. In France, the prevalence of diabetes is 4- 6% of the adult population.\n\nDiabetic kidney disease (DKD) is a growing public health problem and therefore constitutes a major factor in progressive kidney disease. DKD has become the leading cause of end stage kidney disease (ESKD), requiring dialysis or transplantation.\n\nCurrent routine screening for DKD is limited to detecting of impaired glomerular filtration rate (GFR) and\u002For elevated albuminuria, typically manifests in later stages of DKD. Therefore, the current methods to screen for DKD lack the resolution to capture the earliest functional changes associated with DKD.\n\nChronic renal hypoxia plays a crucial role in the development and progression of DKD and may affect Renal hemodynamic.\n\nThe aim to assess the feasibility of the measure of hypoxa-induced renal hemodynamics parameters.",[81,82,83,84,85],"Diabetes","Diabetic Kidney Disease","Hypoxia","Healthy Volunteer","Diabetic Nephropathies","2025-04-07",{"date":88,"type":89},"2025-04-09","ACTUAL",{"date":91,"type":89},"2025-02-13",{"date":93,"type":75},"2026-09",{"name":5,"class":6},1]